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临床试验/CTRI/2025/04/083790
CTRI/2025/04/083790尚未招募不适用

Randomized Control Study of patients post semirigid Ureterorenoscopic Lithotripsy (URSL) with DJ stenting undergoing bladder catheterization vs non-catheterization.

Kasturba Medical College and Hospital Manipal1 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2025年4月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
141
试验地点
1
主要终点
International Prostate Symptom Score (IPSS).

研究概览

简要总结

Patients presenting to Kasturba Hospital Manipal, Department of urology and Renal Transplant with ureteric calculi will be recruited from the OPD for the study.

Informed consent will be taken.

Lithotripsy will be done with pneumatic lithotripter or Laser as per surgeons’ preference.

Clearance of stone fragments will be confirmed on ureteroscopy and fluoroscopy.

Then, Patients will be randomized into 2 groups by using simple computer-generated randomization 

Group 1 patients (control group) will undergo Bladder catheterization and Group 2 patients (study group) will not be subjected to a catheter.

All patients will be evaluated for post operative pain, fever, IPSS and USSQ- pre operatively, POD0- at 6 hr (from the time the patient fully awakens from general anesthesia or regains motor control after spinal anesthesia) and on POD1.

All patients will be prescribed oral antibiotics for one week and oral analgesics for 7 days post discharge.

Ultrasonography of the patients will be done just before the discharge to measure PVR and hydronephrosis.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • URSL performed under general/spinal anesthesia with insertion of Double J ureteral stent Foleys catheter in the control group patient.
  • Foleys no 14 in females and males.

排除标准

  • Age less than 18 years Bilateral URSL URSL without stenting Previous history of URSL Pre existing urethral/Bladder outlet pathology.

结局指标

主要结局

International Prostate Symptom Score (IPSS).

时间窗: Pre-operatively, Post operative POD 0 (6hrs), POD 1

Post-operative pain, Visual Analogue Scale (VAS)

时间窗: Pre-operatively, Post operative POD 0 (6hrs), POD 1

Ureteric Stent Symptomatic Score (USSQ)

时间窗: Pre-operatively, Post operative POD 0 (6hrs), POD 1

次要结局

  • Post operative fever more than 100 degree(USG for Hydronephrosis, Post Void Residue (PVR) seen before discharge)

研究者

发起方
Kasturba Medical College and Hospital Manipal
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Harsh Dinesh Bhalsod

Kasturba Medical College

研究点 (1)

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